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Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Esteve Quimica |
Spain |
ESTEVE QUIMICA SA | 12711 | ENALAPRILAT | 1997-10-21 | Inactive | II | N/A | ||
28/03/2025 | Hikma Pharmaceuticals |
United Kingdom |
HIKMA PHARMACEUTICALS LLC | 19809 | ENALAPRILAT USP | 2006-09-28 | Active | II | N/A |